Trial reportClinical pharmacology in drug development2026
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation Study for the Evaluation of the Safety, Tolerability, and Pharmacokinetics of Recombinant Human Plasma Gelsolin (rhu-pGSN) Following Intravenous Administration to Healthy Volunteers.
Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
Plasma gelsolin (pGSN) is a non-immunosuppressive anti-inflammatory immunomodulator with demonstrated efficacy in animal models of acute lung injury. Its therapeutic potential for moderate-to-severe acute respiratory distress syndrome is currently under investigation. This randomized, double-blind, placebo-controlled study assessed the safety, pharmacokinetics, and immunogenicity of multiple ascending doses of recombinant human pGSN (rhu-pGSN) in healthy volunteers. Thirty-two participants were enrolled across four dose cohorts (6, 12, 18, and 24 mg/kg of body weight), randomized 3:1 to receive five daily intravenous (IV) infusions of rhu-pGSN or placebo. Plasma pGSN concentrations increased as dose increased after single and multiple IV administrations. Following the final dose, geometric mean C
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